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This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone 0.1mg/kg | Experimental | Methadone 0.1mg/kg |
|
| Methadone 0.2mg/kg | Experimental | Methadone 0.2mg/kg |
|
| Methadone 0.3mg/kg | Experimental | Methadone 0.3mg/kg |
|
| Control | Placebo Comparator | No methadone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone 0.1mg/kg | Drug | Subjects will receive methadone as their intraoperative opioid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| R-methadone Plasma AUC 0-96hr/Dose | 96 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Kharasch, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone 0.1mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| FG001 | Methadone 0.2mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| FG002 | Methadone 0.3mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| FG003 | Control | Subjects do not receive methadone as their intraoperative opioid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone 0.1mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| BG001 | Methadone 0.2mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | R-methadone Plasma AUC 0-96hr/Dose | Posted | Mean | Standard Deviation | (ng * hr-1 * ml-1 * mg-1 | 96 hr |
|
4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methadone 0.1mg/kg | Methadone administration 0.1mg/kg Methadone: Subjects will receive methadone as their intraoperative opioid. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Kharasch MD PhD | Washington University | 3143628796 | kharasch@wustl.edu |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Methadone 0.2mg/kg | Drug | Subjects will receive methadone as their intraoperative opioid. |
|
| Methadone 0.3mg/kg | Drug | Subjects will receive methadone as their intraoperative opioid. |
|
| Control | Drug | Subjects will not receive methadone as their intraoperative opioid. |
|
| BG002 | Methadone 0.3mg/kg | Subjects will receive methadone as their intraoperative opioid. |
| BG003 | Control | Subjects do not receive methadone as their intraoperative opioid. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control |
Subjects do not receive methadone as their intraoperative opioid. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Methadone 0.2mg/kg | Methadone administration 0.2mg/kg Methadone: Subjects will receive methadone as their intraoperative opioid | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Methadone 0.3g/kg | Methadone administration 0.3 mg/kg Methadone: Subjects will receive methadone as their intraoperative opioid | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Control | No methadone No methadone: Subjects will not receive methadone as their intraoperative opioid | 0 | 30 | 0 | 30 | 0 | 30 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|